1. Field of the Invention
This invention is directed to a novel device and method for treating body tissues which include neoplastic cells, such as cancerous tissue and non-malignant tumors, to reduce the mass thereof. The device penetrates normal tissue to reach the tissue including the neoplasm and delivers therapeutic ablative energy to the tissue and/or deliver therapeutic substances to the tissue. It limits delivery of the therapeutic treatment to the precise location selected. This device is a cannula device for positioning a treatment assembly in the area or organ containing the neoplasm with at least one stylet in the cannula, mounted for extension from the end of the cannula through surrounding tissue to the tissue targeted for medical treatment. This device is suitable for reducing the mass of any type of tissue, and it is most particularly useful for treating tissue containing neoplastic cells.
2. Discussion of the Related Art
Surgical treatment of cellular tissues usually requires direct contact of target tissue with a medical instrument, usually exposing both the target and intervening tissue to substantial trauma. Often, precise placement of a treatment probe is difficult because of the location of a target tissue in the body or the proximity of the target tissue to obstructions or easily damaged, critical body organs, nerves, or other components.
High-frequency currents are used in electrocautery procedures for cutting human tissue, especially when a bloodless incision is desired or when the operating site is not accessible with a normal scalpel but presents an access for a thin instrument through natural body openings such as the esophagus, intestines or urethra. Examples include the removal of prostatic adenomas, bladder tumors or intestinal polyps. In such cases, the high-frequency current is fed by a surgical probe into the tissue to be cut. The resulting dissipated heat causes boiling and vaporization of the cell fluid at this point, whereupon the cell walls rupture and the tissue is separated. The frequency of the current for this use must be above ca. 300 kHz in order to avoid any adverse nerve and/or muscle responses.
Destruction of cellular tissues in situ has been used in the treatment of many diseases and medical conditions alone or as an adjunct to surgical removal procedures. It is often less traumatic than surgical procedures and may be the only alternative where other procedures are unsafe. Ablative treatment devices have the advantage of using a destructive energy which is rapidly dissipated and reduced to a nondestructive level by conduction and convection forces of circulating fluids and other natural body processes.
Microwave, radiofrequency, acoustical (ultrasound) and light energy (laser) devices, and tissue destructive substances have been used to destroy malignant, benign and other types of cells and tissues from a wide variety of anatomic sites and organs. Tissues treated include isolated carcinoma masses and, more specifically, tissues in organs such as the prostate, glandular and stromal nodules characteristic of benign prostate hyperplasia. These devices typically include a catheter or cannula which is used to carry a radiofrequency electrode or microwave antenna through a duct to the zone of treatment and apply energy diffusely through the duct wall into the surrounding tissue in all directions. Severe trauma is often sustained by the duct wall during this cellular destruction process, and some devices combine cooling systems with microwave antennas to reduce trauma to the ductal wall. For treating the prostate with these devices, for example, heat energy is delivered through the walls of the urethra into the surrounding prostate cells in an effort to kill the tissue constricting the urethra. Light energy, typically from a laser, is delivered to prostate tissue target sites by "burning through" the wall of the urethra. Healthy cells of the duct wall and healthy tissue between the nodules and duct wall are also indiscriminately destroyed in the process and can cause unnecessary loss of some prostate function. Furthermore, the added cooling function of some microwave devices complicates the apparatus and requires that the device be sufficiently large to accommodate this cooling system.
Chemotherapy generally involves systemic delivery of the therapeutic agents, the agents affecting both normal dividing and abnormal cells. Efforts to target neoplastic cells, such as with "bullets" comprising a neoplastic preferentially binding antibody coupled with a cytotoxic agent have had limited success; the agents are removed and concentrated by the liver in the removal process, exposing the liver to high levels of the toxin. Photodynamic therapy seeks to limit the cytotoxic activity to the areas exposed to light energy; however, since the photodynamic agents are administered systemically, epidermal areas exposed to light are also affected, requiring protection from the sun until the photodynamic agents are eliminated from the body.